eCOA Build Programmer

• Location: Indianapolis, IN
• Duration: 6 months
• Experience Required: 8-10 years
• Role: eCOA Build Programmer
• Skills: Life Sciences, Clinical Data Management (CDM), Clinical Database Programming, Overview & Study Setup

Core Responsibilities

• Design, program, and test clinical trial data collection databases.

• Perform mapping, testing, and normalization of data into a clinical data warehouse.

• Apply strong knowledge of:

• Data technology

• Data flow

• Data standards

• Database programming

• Data normalization

• Testing and validation

• Collaborate with study teams to deliver standardized data collection methods and innovative validation solutions for global clinical trials.

• Gather and influence eCOA design specifications for successful trial implementation.

• Program and test data collection systems and associated data repository mappings.

• Use data standards library components for trial or program builds.

• Ensure data collection systems and data warehouse mappings are accurate, efficient, and aligned with study objectives.

• Partner with Clinical Build Programmers to ensure complete data builds.

• Provide insights into study-level deliverables, including:

• Data Management Plan

• Project Plan

• Database

• Observed datasets

• Support submission, inspection, and regulatory response activities.

• Lead complex cross-Business Unit / Therapeutic Area projects and programs.

eCOA / eDC / Clinical Data Experience

• Hands-on programming experience with:

• eCOA (electronic Clinical Outcome Assessment)

• eDC (electronic Data Capture)

• eSource

• Direct Data Capture

• Design electronic CRF screens for clinical data collection.

• Build required validations and edit checks.

• Understand and interpret clinical protocols and clinical terminology.

• Translate clinical requirements into technical specifications.

• Familiarity with clinical data tools, technologies, and workflows for:

• Patient data collection

• Testing

• System validation

• Analyze impacts and implement post-production study design changes.

• Perform data analytics and visualization.

• Understand and articulate the complete data flow from patient to analysis, including data structure and format.

• Apply data-flow knowledge to develop appropriate data solutions.

• Determine appropriate technology platforms, systems, and databases for data acquisition and aggregation.

eCOA Study Build Responsibilities

• Review:

• Clinical protocols

• eCOA requirements

• Instrument specifications

• Translations

• Visit schedules

• Edit-check requirements

• Determine the overall study build scope.

• Configure and program eCOA studies, including:

• Questionnaires

• Diaries

• Assessments

• Visit workflows

• Notifications

• User roles

• Devices

• Data transfer settings

• Translate approved clinical and business requirements into accurate system configurations.

• Maintain end-to-end requirements traceability.

• Prepare and maintain:

• Build specifications

• Configuration documentation

• Test scripts

• Validation evidence

• Release notes

• Deployment records

• Conduct unit testing.

• Support:

• System testing

• Integration testing

• User Acceptance Testing (UAT)

• Regression testing

• Production validation

• Manage defects and change requests.

• Perform impact assessments.

• Troubleshoot configuration and data issues.

• Coordinate issue resolution with platform and vendor teams.

• Work with instrument owners and licensing teams to ensure correct implementation of:

• Approved content

• Scoring rules

• Copyright requirements

• Language versions

Integration & Data Management

• Support integrations and data transfers between eCOA platforms and clinical systems.

• Experience integrating with:

• EDC

• IRT

• CTMS

• Data warehouses

• Analytics environments

• Understand clinical data structures, data mapping, and database architecture.

• Ensure accurate data movement from collection systems through downstream analysis environments.

Programming & Technical Skills

• HTML
• CSS
• JavaScript
• Node.js
• JSON
• SpEL
• SQL
• Data Functions and Procedures
• Relational databases
• Non-relational databases
• MongoDB
• Database structures
• Data mapping
• Clinical data programming
• GitLab utilities
• Data analytics and visualization

Validation, Compliance & Documentation

• Ensure eCOA builds comply with:

• Standard Operating Procedures (SOPs)

• Good Documentation Practices (GDP)

• Validation requirements

• Data privacy expectations

• Applicable regulations

• Support regulatory submissions, inspections, and responses.

• Maintain appropriate validation and audit documentation.

• Support production deployment and study go-live.

• Perform post-production verification.

• Support:

• Maintenance releases

• Study amendments

• Study closeout activities

Project & Team Responsibilities

• Coordinate study build activities across onsite and offshore teams.

• Track:

• Milestones

• Dependencies

• Risks

• Issues

• Provide clear status updates to stakeholders.

• Demonstrate strong leadership in a professional environment.

• Demonstrate strong teamwork and collaboration.

• Communicate effectively with technical and business stakeholders.

• Work effectively with cross-functional teams, instrument owners, vendors, and licensing teams.

• Lead complex cross-functional projects and programs.

Continuous Improvement

• Contribute to reusable:

• Templates

• Standards

• Automation

• Peer-review processes

• Identify opportunities to improve eCOA study build processes.

• Quickly learn and adopt new technology trends.

• Support standardization and continuous improvement initiatives.

Essential Skills

• eCOA Build Programming
• eCOA / eDC / eSource / Direct Data Capture
• Clinical Database Programming
• Clinical Data Management
• Clinical Trial Data Collection
• Electronic CRF Design
• Clinical Protocol Interpretation
• Data Mapping
• Data Normalization
• Database Programming
• HTML / CSS / JavaScript
• Node.js
• JSON
• SpEL
• SQL
• MongoDB
• GitLab
• Data Analytics & Visualization
• Clinical Data Integration
• System Testing & Validation
• UAT / Regression Testing
• Clinical Data Warehouse
• EDC / IRT / CTMS Integration
• Life Sciences / Clinical Research
• Regulatory & Validation Requirements